Summary:
- The FDA has granted approval for Ziihera (zanidatamab), a HER2-targeted bispecific antibody, for the treatment of adult patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma.
- The approval allows for the administration of Ziihera in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without the PD-1 inhibitor tislelizumab, based on significant improvements in progression-free survival observed in clinical trials.